Yiguang Lu

Mr. Yiguang Lu graduated from the School of Medicine at Nanjing University and holds Chinese Laywer qualification.

Mr. Lu currently serves as Vice-Chairman of the Professional Committee on Medical and Health Law of the All-China Lawyers Association, Expert Consultant on Civil and Administrative Cases for the Supreme People's Procuratorate, Chairman of the Administrative Law Professional Committee of the Shanghai Lawyers Association, Vice President of the Shanghai Law Society's Research Association on Life Law, Member of the Shanghai Municipal People's Government Administrative Review Committee.

Mr. Yiguang Lu has long been dedicated to compliance and dispute resolution in the fields of healthcare, pharmaceuticals, and medical insurance. His expertise includes the legality assessment of major decisions and crisis management for medical institutions and pharmaceutical enterprises; compliance matters for pharmaceutical products before and after market approval; and the compliant use of medical insurance funds by designated pharmaceutical companies. He serves as legal counsel for numerous medical institutions, pharmaceutical companies, as well as health and drug regulatory authorities.

Healthcare :

Mr. Lu has a profound understanding of the healthcare industry. Firstly, he has conducted in-depth research on defining whether an activity constitutes medical practice (unlicensed practice) and has handled multiple administrative penalty cases related to unlicensed practice. Secondly, he provides legal opinions regarding whether medical institutions are involved in renting or contracting out departments, practicing beyond their authorized scope, or employing non-healthcare personnel, and he has extensive experience in managing complex medical disputes. Thirdly, Mr. Lu has conducted in-depth research on compliance in international medical tourism, offering professional legal advice on how to conduct cross-border medical services and the use of drugs and medical devices across borders.

Pharmaceuticals:

Mr. Lu has long provided compliance opinions on the research and registration of pharmaceutical products prior to market entry, particularly in areas such as clinical research compliance, key points of ethical review, management of compassionate use of drugs and medical devices, design of informed consent clauses, and resolution of clinical research disputes. He also possesses rich experience in ensuring compliance in the production, distribution, promotion, and use of pharmaceutical products post-market, including responsibilities of Marketing Authorization Holders (MAH), advertising review, cross-border circulation of drugs and medical devices, off-label use, and handling adverse events. Additionally, he has conducted in-depth research on defining drugs (including counterfeit and substandard drugs) and medical devices. Mr. Lu has specialized research on the compliance, promotion, and use of health foods, special medical purpose foods, disinfection products, and cosmetics, which are related to life and health. He has systematically researched legal risk management for pharmaceutical companies expanding overseas, including contract risk prevention, overseas cooperation pathways, and regulatory differences in various regions.

Medical Insurance:

Mr. Lu has handled numerous cases involving the use of medical insurance funds, assisting companies in resolving administrative disputes with medical insurance departments, representing them in hearings, administrative reviews, and administrative litigation, and managing cases that intersect with criminal law to protect the legal rights of defendants. He also provides specialized legal services and training for pharmaceutical companies to ensure compliant use of medical insurance funds.

Publications:

Mr. Lu has authored several books, including but not limited to "Practical Legal Risk Management for Medical Institutions and Pharmaceutical Companies," "Analysis of Typical Cases in Medical Compliance," and "Legal Practice and Typical Cases in Medical Aesthetics."

Honors:

In 2011, Mr. Lu was honored as an "Outstanding Young Lawyer in Shanghai." In 2023, he was awarded the title of "Fifth Oriental Distinguished Lawyer."